JOB SUMMARY 

Coordinate activities related to Clinical Trial Applications, according to local regulations and requirements. This includes HA query management. 

Interact with key stakeholders, such as the PCOs, Hub Regulatory Strategists, Product Strategists, Submissions Management, Global Product Development, and third party vendors, to ensure the regulatory strategy has been executed in a timely manner.  

Familiarize with the latest changes in BoH legislation, and communicate it to all relevant stakeholders, to ensure the necessary systems and databases are updated as necessary. 

Work in collaboration across the region to deliver efficiencies in regulatory submissions and processes. 

JOB RESPONSIBILITIES  

• Working with Regulatory Country Lead, Liaise with clinical research project managers to seek to understand clinical research program.  

• In partnership with above-country operational hubs, above-country WSR strategists, and local clinical operations or third party vendors, prepare agreed CTA submission documentation for both initial application and subsequent amendments, and other maintenance activities for the lifecycle of the CTA including response to Regulatory Authority queries.  

• Ensure timely communication of any GCP breaches, or actions taken for safety reasons.  

• Along with the Country/Cluster Lead, contribute to enhance the relationships with Regulatory Authorities and trade associations with the objective to promote and facilitate clinical development in the country.       

• Possess a thorough understanding of the market regulatory requirements, as well as the regulatory processes for CTA applications.  

• Coordinate the activities related to CTAs and maintenance to Health authorities 

• Work in partnership with key stakeholders including but not limited to the Regional Regulatory Hub Strategy (RRHS), WRO, WSR, GPD, GCMC, GSCPM, to ensure submissions are ready to file, and provide the necessary information to ensure internal systems and databases are updated. 

• Coordinate the routine monitoring of BoH website for information related to CTA registration, and changes status. Understand local regulations and trends. 

• Ensure the Regulatory team keeps current with the agency legislations, as well as updates the regulatory information on LatAm SP & Pfizer databases (as applicable). 

• Coordinate the review of submission ready dossiers, ensuring that submissions fully meet the local regulatory requirements. This includes BoH query response. 

• Work in partnership with the PCOs, RRHS and stakeholders, as applicable. 

• Review and ensure processes related to exportation documents. 

• Contact the BoH by elaborating documents, e-mails, phone contacts and meetings for following-up processes of CTAs approval. 

• Complete departmental training in a timely manner to address corporate and regulatory needs. 

• As applicable, contribute to local regulatory initiatives promoting a culture aligned with Pfizer values and which supports compliance, innovation. 

QUALIFICATIONS / SKILLS  

Technical skills 

• Knowledge of local BoH requirements about Clinical Trials Applications  

• Technical and scientific knowledge of pharmaceutical products 

• Proficiency in the English language  

Managerial skills 

• Customer-oriented; Results-oriented; Negotiation; Planning; Organized; Decision making; Communication; Development of colleagues; Team player; Change agile. 

Certifications 

• N/A 

Education 

• Pharmacy or life sciences degree   

Experience 

• Previous experience and proven track record in management of Clinical Trial Applications.

ORGANIZATIONAL RELATIONSHIPS 

• Work in partnership with key stakeholders including but not limited to the Regional Regulatory Hub Strategy (RRHS), WRO, WSR, GPD, GCMC, GSCPM, to ensure submissions are ready to file, and provide the necessary information to ensure internal systems and databases are updated. 

• Work in partnership with the PCOs, RRHS and stakeholders, as applicable. 

• Contact the BoH by elaborating documents, e-mails, phone contacts and meetings for following-up processes of CTAs approval. 

• Along with the Country/Cluster Lead, contribute to enhance the relationships with Regulatory Authorities and trade associations with the objective to promote and facilitate clinical development in the country. 

OTHER JOB DETAILS

• Last date to Apply for job: April 4th, 2024
• Location: São Paulo - Dumas Office

EEO (Equal Employment Opportunity) & Employment Eligibility 

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.